Rotating stent delivery system for side branch access and protection and method of using same

ABSTRACT

A catheter assembly and method of use comprises advancing a catheter having a rotatably mounted balloon relative to the primary guide wire to a vessel bifurcation along first and second guide wires.

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority from U.S. provisionalapplication No. 60/314,467, filed Aug. 23, 2001 the entire contents ofwhich are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH

[0002] Not Applicable

BACKGROUND OF THE INVENTION

[0003] 1. Field of the Invention

[0004] At least one embodiment of the present invention is directed tothe field of stents and stent delivery systems used to treat stenoses,and more particularly to stenoses at a bifurcation of a passage.

[0005] 2. Description of the Related Art

[0006] Stent systems are widely used in the treatment of stenoses.Intravascular stents are used in coronary, renal, and carotid arteries,for example, to maintain an open passage through the artery. In patientswhose coronary heart disease consists of focal lesions, stents haveproven effective. For example, where only a single coronary artery isclogged or where there are short blockages in more than a single artery,stents have been used with a great amount of success. An intravascularstent may be positioned in a clogged artery by a catheter and is oftenset in place by inflating a balloon upon which the stent is mounted.This expands the diameter of the stent and opens the previously cloggedartery. The balloon is then deflated and removed from the patient whilethe stent retains an open passage through the artery.

[0007] It is recognized, however, that a stent can be deployed inmanners other than inflating and deflating a balloon. For example,self-expanding stents have been developed in which a cover is removedfrom over a stent, thereby allowing the stent to deploy or spring intoplace. It is also contemplated that other deployment mechanisms or meansmay be used or developed to advantageously deliver and deploy a stent inposition.

[0008] Nevertheless, a need still exists for properly delivering andlocating a stent at a bifurcation. Although efforts have been made touse a stent at bifurcations, these sites have previously beeninadequately treated by a stent. For example, U.S. Pat. No. 5,749,825 isrepresentative of a catheter system that treats stenoses at an arterialbifurcation. The disclosure of U.S. Pat. No. 5,749,825 is herebyincorporated by reference.

[0009] A stent having different diameters has been proposed to allowplacement in both a main passage, such as an artery, and a side branchpassage, such as a continuation branch artery. Additionally, thesestents generally have a circular opening which allows for unimpededblood flow into the side branch artery. However, problems are stillencountered in orienting the stent relative to the side branch at thebifurcation of the main and branch passages.

[0010] Many current devices rely on either passive torque (e.g., pushingthe stent forward and allowing the stent that is fixed on the guidewire/balloon to passively rotate itself into place) or creating torquefrom outside of the patient to properly orient the stent delivery systemin the passage. These devices and methods of achieving proper angularorientation have not been shown to be effective in properly placing andpositioning the stent. As will be appreciated and understood by thoseskilled in the art, improper placement of the stent with respect to itsrotational or circumferential orientation, or its longitudinalplacement, could lead to obstruction of the side branch passage. It isimportant to properly position or center an opening formed in thebifurcated stent with the side branch passage to maximize flowtherethrough.

[0011] Thus, a need exists for effectively treating stenosed passagebifurcations. This need includes more precise and exact longitudinalplacement and rotational/ circumferential orientation of the stent.

[0012] Commercially available devices do not maintain side branch accessat the time of stent deployment. This results in the potential forplaque shift and occlusion of the side branch passage.

[0013] It would also be advantageous if stents could be placed acrossthe side branch while wire position is maintained thereby helping toprotect and secure further access to the side branch.

[0014] All US patents and applications and all other published documentsmentioned anywhere in this application are incorporated herein byreference in their entirety.

[0015] Without limiting the scope of the invention a brief summary ofsome of the claimed embodiments of the invention is set forth below.Additional details of the summarized embodiments of the invention and/oradditional embodiments of the invention may be found in the DetailedDescription of the Invention below.

[0016] A brief abstract of the technical disclosure in the specificationis provided as well only for the purposes of complying with 37 C.F.R.1.72. The abstract is not intended to be used for interpreting the scopeof the claims.

BRIEF SUMMARY OF THE INVENTION

[0017] Some embodiments of the present invention include a freelyrotating deployment system for a stent assembly maintaining side branchaccess and protection.

[0018] The present invention contemplates a new and improved apparatusand method that improves the orientation of a stent by providing a moreexact placement of the stent relative to the side branch passage. This,in turn, leads to better protection of the side branch passage. Thepresent invention has the potential for improvement in trackability ofthe stent delivery system.

[0019] At least one embodiment of the invention includes a freelyrotatable catheter balloon surrounding a main hollow member or hypotube.The stent surrounds both the catheter balloon and the main hypotube. Aside branch hollow member or side branch hypotube is attached to thecatheter balloon and lies underneath the stent. A distal end of the sidebranch hypotube exits the stent at a desired longitudinal position whilea proximal end of the side branch hypotube extends beyond the proximalend of the stent. At the distal exit point, the stent includes anopening that, after deployment of the stent, allows for blood flowthrough the ostium of the side branch artery.

[0020] The balloon is connected to the stent delivery system. In someembodiments, the balloon is attached both distally and proximally torotate freely about the main hypotube. The rotating members rotate aboutthe main hypotube and are limited longitudinally by first and secondfixed members non-rotatably secured to the main hypotube. The balloonstent assembly rotates freely about the axis defined by the mainhypotube and any radial movement is limited by the main hypotube. Thisconstruction allows the side branch guide wire to direct the stentassembly to rotate freely and passively to the proper circumferentialorientation. Upon inflating the balloon, the fixed and rotated memberssecure the circumferential orientation of the stent delivery system.Thus, the side branch guide wire properly orients the stent deliverysystem in its correct position relative to the side branch.

[0021] A primary feature of some embodiments is that at the time ofpositioning the stent, the stent will be properly oriented relative tothe side branch, i.e., a stent delivery system and method that correctlypositions the stent in a bifurcated passage.

[0022] Another advantageous feature is side branch protection with theguide wire during stent deployment.

[0023] Another benefit of this invention resides in proper alignment ofthe stent delivery system in a bifurcated passage to achieve correctcircumferential orientation relative to a side branch passage, andsecuring the desired orientation.

[0024] Yet another benefit of this invention is the ability to properlyplace the stent delivery system longitudinally relative to the sidebranch.

[0025] A further advantage of the system is that tangled wires pose lessof a problem.

[0026] These and other embodiments which characterize the invention arepointed out with particularity in the claims annexed hereto and forminga part hereof. However, for a better understanding of the invention, itsadvantages and objectives obtained by its use, reference should be madeto the drawings which form a further part hereof and the accompanyingdescriptive matter, in which there is illustrated and described aembodiments of the invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0027] A detailed description of the invention is hereafter describedwith specific reference being made to the drawings.

[0028]FIG. 1 is a cross-sectional side view of a rotating stent deliverycatheter assembly for stenting an arterial bifurcation in itspre-deployment configuration, with the catheter balloon shown inflated.

[0029]FIG. 2 is a perspective view of the stent delivery assembly ofFIG. 1 shown with a stent disposed about the balloon.

[0030]FIG. 3 is a perspective view of the stent delivery catheterassembly of FIG. 1 as it would appear in the collapsed state prior tohaving a stent mounted on the balloon.

[0031]FIG. 4 is a perspective view of a stent delivery system with theballoon in an inflated state and the side branch hypotube in an opencondition.

[0032]FIG. 5 is an enlarged view of the distal exit point of the sidebranch hypotube and the opening of the rotating stent delivery catheterassembly of FIG. 2.

[0033]FIG. 6 is a perspective view of a proximal shaft of an alternatestent delivery catheter assembly having only one rotating joint that isself sealing when pressure is applied or withdrawn.

[0034]FIG. 7 is an enlarged side view of a distal end of the rotatingballoon assembly associated with FIG. 6.

[0035]FIG. 8 is an enlarged side view of the combined components ofFIGS. 6 and 7, specifically portions of the distal end of the proximalfixed shaft in FIG. 6 combined with the proximal end of the freelyrotatable distal portion in FIG. 7 creating a rotating stent deliverycatheter assembly with a single rotating joint that is self sealing.

[0036]FIG. 9 is an enlarged side elevational view of FIGS. 6 and 7showing the combined of components of FIGS. 6-8 in their entirety.

DETAILED DESCRIPTION OF THE INVENTION

[0037] While this invention may be embodied in many different forms,there are described in detail herein specific preferred embodiments ofthe invention. This description is an exemplification of the principlesof the invention and is not intended to limit the invention to theparticular embodiments illustrated.

[0038] For the purposes of this disclosure, like reference numerals inthe figures shall refer to like features unless otherwise indicated.

[0039] Referring now to the drawings wherein the showings are for thepurposes of illustrating the preferred embodiments of the invention onlyand not for purposes of limiting same, FIG. 1 shows a stent deliverysystem or assembly 10. Assembly 10 includes a first guide member, ormain guide wire 12 that extends axially through a first hollow ortubular member 14. The first hollow member 14 will also be identified asa main hypotube, although it will be appreciated that the particularshape or configuration of this component may change from thatillustrated in the drawings. The main guide wire 12 is used as thedelivery guide of the stent catheter assembly 10 to a stenosed region ofa passage such as an artery (not shown). The main hypotube 14 ispreferably a hollow cylinder with openings on both its distal andproximal ends, respectively end 16 and end 18, which allows for passageof the main guide wire 12 therethrough. A first fixed member, or distalfixed body 20 and a second fixed member, or proximal fixed body 22 arenon-rotatably secured to distal end 16 and proximal end 18 of the mainhypotube 14. Although described as separate elements, it will beunderstood that the fixed bodies 20 and 22 and the main hypotube 14 canbe separate components that are secured together or an integrally formedassembly if desired for ease of manufacture or assembly. The fixedbodies 20 and 22 are preferably tapered from smaller diameter, axiallyouter ends to larger diameter, intermediate ends for reasons that willbecome more apparent below.

[0040] A first rotating member or distal rotating member 24 and a secondrotating member or proximal rotating member 26 are axially spaced apartand located between the distal fixed body 20 and proximal fixed body 22.The rotating members 24 and 26 are preferably of the same generaldiameter throughout their length and rotate freely about the axis of themain hypotube 14.

[0041] Sealed to the proximal and distal rotating members 24 and 26 areopposite ends of a catheter balloon 28. A distal end 30 of the catheterballoon is sealingly joined to (or integrally formed with) the distalrotating member 24 while a proximal end 32 of the catheter balloon issealingly joined to (or integrally formed with) the proximal rotatingmember 26. Thus, the balloon is free to rotate relative to the mainhypotube, a feature that provides advantages and benefits over knownstent assemblies. It is also contemplated that the rotating members 24and 26 can be formed of sealing or elastomeric material (or incorporatea separate seal member) so that slight axial movement of the balloon 28and of the rotating members 24 and 26 engages and seals against thefixed bodies 20 and 22 upon inflation of the balloon 28. The balloon 28and the rotating members 24 and 26 can hold high pressure and seal atthe ends. It will be appreciated that the rotating members 24 and 26 arepreferably constructed to maintain a cylindrical configuration underpressure so that the balloon 28 is free to rotate relative to the mainhypotube 14 when pressurized.

[0042] In some embodiments the stent delivery catheter system furtherincludes an outer hollow/tubular member or outer hypotube 40 receivedover the main hypotube 14. The outer hypotube 40 is radially spaced fromthe main hypotube 14 at a first or proximal end 42 to define an annularspace 43 through which fluid from an external source (not shown) isintroduced to inflate the balloon. In at least one embodiment, a secondor distal end 44 of the outer hypotube 40 is sealed to the main hypotube14 so that fluid cannot escape therefrom. Alternatively, the distal endof the outer hypotube extends only partially into the balloon 28. Inaddition, one or more openings, or contrast ports, 46 are provided inthe outer hypotube 40 at a location within the balloon 28 so that thefluid can enter the cavity defined between the balloon 28 and the outerhypotube 40 as illustrated by the directional arrows in FIG. 1.Alternatively, the opening 46 may define the distal end of the outerhypotube 40. In at least one embodiment, the balloon 28 is fullyinflated at the proximal end 42 and then begins to inflate at the distalend 44. The outer hypotube 40 may be advantageously and integrallyformed with the first and second fixed members 20 and 22 for ease ofmanufacture, although it will be appreciated that these may be separatemembers without departing from the scope and intent of the invention.

[0043] A conventional or specially designed medical device, such as astent 50, encloses a portion of the catheter balloon 28, such as isshown in FIG. 2. The stent 50 is typically a metal sleeve of meshconstruction that is advanced into the stenosis riding on the balloon 28of the catheter assembly 10. Once properly positioned, the balloon 28 isinflated with an inflation fluid, such as saline and contrast, throughthe passage 43 between the main hypotube 14 and the outer hypotube 40,which expands the balloon 28 and expands or radially opens the stent 50to compress an atheroma that is narrowing the passage wall. Although theballoon 28 is subsequently deflated for removal from the patient withthe catheter assembly 10, the stent 50 remains in its expanded stateallowing increased flow through the previously closed/blocked (stenosedor narrowed) region. Alternatively, a self-expanding stent not requiringa balloon for delivery or deployment can be used without departing fromthe scope and intent of the present invention.

[0044] A second or branch tubular member 60, also referred to as a sidebranch hypotube, is provided between the catheter balloon 28 and thestent 50. As evident in FIG. 2, the side branch hypotube 60 carries orreceives a side branch guide wire 62. The side branch hypotube 60extends from the proximal end of the stent 50 between the stent andballoon and exits the stent at an intermediate longitudinal positionthrough an opening 64. The opening 64 provides for both the exit of theside branch hypotube 60, as well as the unobstructed passage of bloodflow into the side branch passage once the stent has been deployed. Itshould be understood, however, that the side branch hypotube opening 64could be placed at any convenient position along the stent.

[0045] An enlarged view of the side branch hypotube opening 64 in thestent 50 is shown in FIG. 5. The side branch hypotube 60 exits fromunderneath the proximal end of the stent. Upon deployment of the stent50, the side branch hypotube opening 64 allows for unobstructed bloodflow to the ostium of the side branch passage. As will also beappreciated, the side branch hypotube 60 is fixed or secured to theexterior of the balloon. Thus, the side branch hypotube 60, balloon 28,and rotating members freely rotate as a unit relative to the mainhypotube 14 for accurate, passive positioning with the side guide wireand thus accurate positioning of the stent 50 relative to a saddle pointof the bifurcated passage. With continued reference to FIG. 2, thecatheter balloon 28 is inflated, the stent 50 is deployed, and therotating members 24 and 26 are interlocked with the fixed members 20 and22 to stop the rotating action of the stent delivery system and create apressure tight system.

[0046] The side branch hypotube 60 may also be slit 66 along itslongitudinal length to facilitate removal of the side guide wire 62 asis shown in FIGS. 3 and 4. The side branch hypotube 60 is secured to theballoon 28 along its length at a circumferential location opposite thelongitudinal slit, i.e., diametrically opposite the slit 66. The naturalelasticity of the side branch hypotube 60 is utilized so that when theballoon 28 is inflated, such as is shown, the side branch hypotube 60 issubstantially cylindrical in shape to enclose the portion of the sideguide wire 62 therein such as is shown in FIG. 2. When the balloon isinflated, it exerts a tensile force on the side branch hypotube 60 thatopens the hypotube 60 along its length, such as in the manner shown inFIG. 4. As a result the side guide wire 62 is released through the slit66. When the balloon 28 is deflated, such as is shown in FIG. 3, theside branch hypotube 60 again adopts a cylindrical conformation wherebythe remainder of the stent delivery system (balloon and catheter) can beeasily removed.

[0047] The split side branch hypotube 60 offers another desirablefeature. The split hypotube 60 allows for immediate placement of asecond balloon into the side branch for simultaneous “kissing” ballooninflation. In other words, first and second balloons are simultaneouslylocated in the main and side branch passages such that their proximalends abut and their distal ends are placed in each respective branch.This is to be contrasted with use of an unsplit or solid side branchhypotube which would require removal of the first balloon prior toinsertion of a balloon in the side branch.

[0048] An alternative rotating stent delivery system is illustrated inFIGS. 6-9. For purposes of brevity, like components will be referencedby like numerals with a primed suffix (′) and new elements will beidentified by new numerals.

[0049] A proximal shaft is generally well known in the art and may takenumerous forms; however, the proximal shaft 70 shown in FIGS. 6-9preferably includes a bushing 72 at a distal end and a seal 74 comprisedof a soft material. The seal 74 is connected to the proximal shaft 70and, as shown, tapers to a smaller diameter and envelops the mainhypotube 14′, as is shown in FIGS. 8 and 9. Within lumen 76 of theproximal shaft 70, the bushing 72 abuts against an interior distal endof the proximal shaft.

[0050] With reference now to FIG. 7, a distal rotating portion ofproximal shaft 70 is shown. A separate hypotube 14′ includes a proximalend with a first bushing 80 and a second bushing 82 axially spacedtherefrom along the separate hypotube 14′. A second seal 84 comprised ofa soft material, is connected to the first bushing 80 at the proximalend of the separate hypotube 14′. The annular second seal 84 protrudessubstantially parallel along the longitudinal axis of the main hypotubeand extends axially beyond an opening 86 for the main branch guide wire(not shown). Additionally, a third annular seal 88 is shown connected tothe first bushing 80. The third seal 88 has a smaller diameter and liesaxially and radially inward of the second seal 84. The third seal 88 isalso secured to the first bushing 80 of the separate hypotube 14′ andtapers radially inward as it extends longitudinally in a direction awayfrom the separate hypotube 14′, to envelope the main guide wire 12′.

[0051] The integration of the proximal end of the separate hypotube 14′and the distal end of the proximal shaft 70 is shown in FIG. 8.Particularly, the first and second bushings 80, 82 of the hypotube 14′are of a diameter that allows them to fit under or within the particularcomponents of the proximal shaft 70. Specifically, the second bushing 82of the hypotube 14′ is distal to the proximal shaft bushing 72 and isenveloped by the first soft seal 74 of the proximal shaft 70. The firstbushing 80 of the hypotube 14′ is adjacent to the bushing 72 of theproximal shaft and is enveloped by the proximal shaft 70.

[0052] With continued reference to FIG. 8, the integrated hypotube 14′and proximal shaft 70 are shown in a freely rotatable position. In thismode, the hypotube 14′ rotates freely while the proximal shaft 70remains fixed. Positive pressure allows the seals 82 and 88 extendingfrom the first bushing 80 of the hypotube 14′, to contact the proximalfixed shaft 70 and main guide wire 12′ hence sealing the balloondelivery system 10′ allowing for all positive pressure to be transferredto the balloon 28′. This provides for expansion of the balloon 28′ anddeployment of a stent such as previously described. Alternatively, as isshown in FIG. 9 negative pressure applied within the shaft 70 willcreate contact between the separate hypotube and the seal 74 of theproximal shaft 70. Also, contact will be created at the distal end ofthe separate hypotube between the soft material and the wire 12′creating a seal there as well. These seals allow for all negativepressure to be transmitted to the balloon allowing for collapse and thenremoval of the balloon.

[0053] Thus, it is apparent that a truly unique feature of the inventionis a freely rotating stent assembly that provides a more exact placementof the stent relative to the side branch passage.

[0054] The invention has been described with reference to the preferredembodiments. Obviously, modifications and alterations will occur toothers upon a reading and understanding of this specification. Forexample, the illustrated embodiments use a balloon to expand the stentalthough, as briefly noted above, a self expanding or self deployingstent can be used without departing from the features of the presentinvention. Likewise, using a fixed wire on the distal end of theapparatus is also recognized as being consistent with the features ofthe present invention. Moreover, the preferred embodiments describe aside branch hypotube, either split or unsplit, that is associated withthe side branch guide wire. It will be further appreciated that the sidebranch guide wire could be carried and/or released in a variety of otherways. The invention is intended to include all such modifications andalterations thereof.

[0055] The above disclosure is intended to be illustrative and notexhaustive. This description will suggest many variations andalternatives to one of ordinary skill in this art. All thesealternatives and variations are intended to be included within the scopeof the claims where the term “comprising” means “including, but notlimited to”. Those familiar with the art may recognize other equivalentsto the specific embodiments described herein which equivalents are alsointended to be encompassed by the claims.

[0056] Further, the particular features presented in the dependentclaims can be combined with each other in other manners within the scopeof the invention such that the invention should be recognized as alsospecifically directed to other embodiments having any other possiblecombination of the features of the dependent claims. For instance, forpurposes of claim publication, any dependent claim which follows shouldbe taken as alternatively written in a multiple dependent form from allprior claims which possess all antecedents referenced in such dependentclaim if such multiple dependent format is an accepted format within thejurisdiction (e.g. each claim depending directly from claim 1 should bealternatively taken as depending from all previous claims). Injurisdictions where multiple dependent claim formats are restricted, thefollowing dependent claims should each be also taken as alternativelywritten in each singly dependent claim format which creates a dependencyfrom a prior antecedent-possessing claim other than the specific claimlisted in such dependent claim below.

[0057] This completes the description of the preferred and alternateembodiments of the invention. Those skilled in the art may recognizeother equivalents to the specific embodiment described herein whichequivalents are intended to be encompassed by the claims attachedhereto.

1. A catheter assembly comprising: an elongate guide member, theelongate guide member extending from a proximal end to a distal end ofthe catheter assembly; a tubular member disposed about a portion of theelongate guide member, the tubular member rotatable about the elongateguide member; an expandable medical balloon having a proximal end and adistal end, the medical balloon disposed about at least a portion of thetubular member, the proximal end and the distal end of the medicalballoon fixedly engaged to the tubular member; and a proximal shaftmember, the proximal shaft member disposed about a portion of theelongate guide member, the proximal shaft member having a distal endregion, the distal end region being disposed about a proximal end regionof the tubular member, the tubular member passively rotatable relativeto the proximal shaft.
 2. The catheter assembly of claim 1 wherein thetubular member defines an inflation port, the inflation port constructedand arranged to transmit an inflation media to and from the medicalballoon from and to the proximal end of the catheter assembly.
 3. Thecatheter assembly of claim 1 wherein the distal end region of theproximal shaft member is sealingly engaged to the proximal end region ofthe tubular member.
 4. The catheter assembly of claim 1 wherein theproximal end region of the tubular member comprises a first bushing andthe distal end region of the proximal shaft member comprises a secondbushing, the first bushing engaged to the second bushing to form a fluidtight seal between the proximal end region of the tubular member and thedistal end region of the proximal shaft member.
 5. The catheter assemblyof claim 4 wherein the proximal end region of the tubular member furthercomprises a third bushing, the second bushing positioned between thefirst bushing and the second bushing.
 6. The catheter assembly of claim3 further comprising a first annular seal, the first annular sealextending from the distal end region of the proximal shaft member to theproximal end region of the tubular member.
 7. The catheter assembly ofclaim 6 wherein the first annular seal tapers from a first end engagedto the distal end region of the proximal shaft member to a narrowersecond end engaged to the tubular member.
 8. The catheter assembly ofclaim 7 further comprising a second annular seal, the second annularseal extending from the distal end region of the proximal shaft memberto the proximal end region of the tubular member, the second annularseal being positioned proximal to the first annular seal.
 9. Thecatheter assembly of claim 8 further comprising a third annular seal,the third annular seal extending from the proximal end region of thetubular member to the elongate guide member.
 10. The catheter assemblyof claim 9 wherein the third annular seal tapers from a first endengaged to the proximal end region of the tubular member to a narrowersecond end engaged to the elongate guide member.
 11. The catheterassembly of claim 1 wherein a proximal end region of the tubular memberis sealingly engaged to the elongate guide member.
 12. The catheterassembly of claim 11 further comprising a third annular seal, the thirdannular seal extending from the proximal end region of the tubularmember to the elongate guide member.
 13. The catheter assembly of claim1 further comprising an expandable and implantable medical device, theexpandable and implantable medical device being removably disposed aboutat least a portion of the medical balloon.
 14. A catheter assemblycomprising: an elongate guide member, the elongate guide memberextending from a proximal end to a distal end of the catheter assembly;a tubular member disposed about a portion the elongate guide member, thetubular member rotatable about the elongate guide member; a medicalballoon having a proximal end and a distal end, the medical balloondisposed about at least a portion of the tubular member, the proximalend and the distal end of the medical balloon fixedly engaged to thetubular member; and a proximal shaft member, the proximal shaft memberdisposed about a portion of the elongate guide member, the proximalshaft member having a distal end region, the distal end region of theproximal shaft member being disposed about a proximal end region of thetubular member, the distal end region of the proximal shaft member andthe proximal end region of the tubular member forming a fluid tight sealtherebetween, the tubular member being passively rotatable relative tothe proximal shaft member.
 15. The catheter assembly of claim 14 furthercomprising a stent, the stent being disposed about at least a portion ofthe medical balloon, the stent being expanded from a reduced state to anexpanded state when the medical balloon is expanded.
 16. A catheterassembly comprising: an elongate guide member, the elongate guide memberextending from a proximal end to a distal end of the catheter assembly;an inner tubular member, the inner tubular member disposed about aportion of the elongate guide member; an outer tubular member, the outertubular member disposed about at least a portion of the inner tubularmember; a proximal rotatable member and a distal rotatable member, theproximal rotatable member being disposed about a proximal portion of theouter tubular member, the distal rotatable member being disposed aboutat least one of the distal portion of the inner tubular member and thedistal portion of the outer tubular member, the proximal rotatablemember forming a slidable and rotatable fluid seal with the proximalportion of the outer tubular member and the distal rotating memberforming a slidable and rotatable fluid seal with the at least one of thedistal portion of the inner tubular member and the distal portion of theouter tubular member; and a medical balloon expandable between a firststate and a second state, the medical balloon having a proximal end anda distal end, the proximal end of the medical balloon being engaged tothe proximal rotatable member and the distal end of the medical balloonbeing engaged to the distal rotatable member.
 17. The catheter assemblyof claim 16 wherein the proximal portion of the outer tubular member andthe inner tubular member define a space, the space defining an inflationlumen.
 18. The catheter assembly of claim 17 wherein at least a portionof the outer tubular member underlying the medical balloon defines atleast one inflation port, the at least one inflation port in fluidcommunication with the inflation lumen.
 19. The catheter assembly ofclaim 16 wherein the distal rotatable member is disposed about thedistal portion of the outer tubular member.
 20. The catheter assembly ofclaim 19 wherein the distal portion of the outer tubular member issealingly engaged to the distal portion of the inner tubular member. 21.The catheter assembly of claim 16 further comprising a proximal stopmember and a distal stop member, the proximal stop member being fixedlyengaged to the proximal portion of the outer tubular member, the distalstop member being fixedly engaged to at least one of the distal portionof the inner tubular member and the distal portion of the outer tubularmember.
 22. The catheter assembly of claim 21 wherein the proximal stopmember is positioned proximally adjacent to the proximal rotatablemember and the distal stop member is positioned distally adjacent to thedistal rotatable member.
 23. The catheter assembly of claim 22 whereinwhen the medical balloon is expanded from the first position to thesecond position the proximal rotatable member is moved longitudinally toengage the proximal stop member and distal rotatable member is moveddistally to engage the distal stop member.
 24. The catheter assembly ofclaim 16 further comprising a secondary tubular member, the secondarytubular member being engaged to an external surface of the medicalballoon.
 25. The catheter assembly of claim 24 wherein the secondarytubular member has an open position and a closed position, in the closedposition the secondary tubular member defining a substantially hollowinterior open at both ends, the substantially hollow interior definingsecondary lumen, the secondary lumen constructed and arranged to receivea secondary elongate guide member therethrough, in the open position thesecondary tubular member defines a longitudinal opening that exposes thesecondary lumen thereby releasing the secondary elongate guide memberfrom the secondary tubular member.
 26. The catheter assembly of claim 25wherein the secondary tubular member is disposed about a secondaryelongate guide member, the secondary tubular member being moveablerelative to the secondary elongate guide member.
 27. The catheterassembly of claim 26 further comprising a stent, the stent comprising asubstantially hollow tubular member having a plurality of openingstherethrough, the stent being disposed about at least a portion of themedical balloon when the stent is in the unexpanded position, the stentbeing expandable from the unexpanded position to an expanded position,the stent being in the unexpanded position when the balloon is in thefirst state, the stent being in the expanded position when the medicalballoon is in the second state.
 28. The catheter assembly of claim 27wherein the stent is selected from the group consisting of a balloonexpandable stent, a self-expanding stent and any combination thereof.29. The catheter assembly of claim 26 wherein the secondary tubularmember is positioned between at least a portion of the stent and themedical balloon.
 30. The catheter assembly of claim 29 wherein thesecondary elongate guide member exits the secondary tubular member andpasses through one of the plurality of openings through thesubstantially hollow tubular member of the stent.
 31. A method ofplacing a stent at a bifurcation comprising the steps of: advancing afirst guide wire through a body lumen to a first branch of a vesselbifurcation; advancing a second guide wire through the body lumen to asecond branch of the vessel bifurcation; advancing a catheter assemblyto the vessel bifurcation along the first guide wire and a second guidewire, the catheter assembly comprising: a medical balloon disposed aboutthe first guide wire, the medical balloon being freely rotatable aboutthe first guide wire, a tubular member engaged to an external surface ofthe medical balloon, the tubular member being disposed about the secondguide wire, and a stent, the stent being disposed about at least aportion of the medical balloon and the tubular member, the second guidewire passing through at least one opening defined by the stent.
 32. Adelivery assembly for precisely positioning a stent at a bifurcatedpassage, the assembly comprising: a first guide wire adapted for receiptinto a passage; a side branch guide wire adapted for receipt into a sidebranch passage; and a stent assembly carried by the first guide wire andoperatively associated with the side branch guide wire, the assemblyhaving proximal and distal ends, selectively rotatable relative to thefirst guide wire whereby the side branch guide wire is properlypositioned in the side branch passage.
 33. The delivery assembly ofclaim 32 further comprising an inner hollow member receiving the firstguide wire therethrough.
 34. The delivery assembly of claim 33 furthercomprising a balloon received on the inner hollow member for deployingthe stent assembly.
 35. The delivery assembly of claim 34 wherein theballoon rotates relative to the inner hollow member.
 36. The deliveryassembly of claim 34 wherein the inner hollow member has an opening thatoperatively communicates with an interior of the balloon.
 37. Thedelivery assembly of claim 33 further comprising first and second fixedmembers disposed in axially spaced relation on the inner member.
 38. Thedelivery assembly of claim 37 further comprising a balloon axiallyreceived between the fixed members.
 39. The delivery assembly of claim33 further comprising first and second rotatable members received on theinner hollow member, the rotatable members secured to first and secondends of a balloon to permit selective rotation of the balloon andpassively orient the side branch guide wire in the side branch passage.40. The delivery assembly of claim 39 wherein the inner hollow memberforms a fluid passage that conveys fluid to the balloon.
 41. Thedelivery assembly of claim 32 further comprising a carrier for the sidebranch guide wire carried on the balloon.
 42. The delivery assembly ofclaim 41 wherein the carrier includes a longitudinal slit thatselectively opens in response to inflation of the balloon for releasingthe side branch guide wire.
 43. A method of delivering a stent to astenosed bifurcated passage comprising the steps of: inserting a mainguide wire, balloon, and stent in a passage; inserting a side branchguide wire at a side branch passage; and allowing the stent to rotaterelative to the main guide wire to properly orient same.
 44. Thedelivery method of claim 43 comprising inflating a balloon to deploy thestent.
 45. The delivery method of claim 44 further comprising releasingthe side branch guide wire in response to inflating the balloon.
 46. Theassembly of claim 45 wherein the releasing step includes opening a sidetube secured to the balloon to release the side branch guide wire.
 47. Astent delivery assembly for a bifurcated passage comprising: a firstguide wire for receipt in a main branch of the bifurcated passage; asecond guide wire for receipt in a side branch of the bifurcatedpassage; and a stent carried by the first guide wire and operativelyassociated with the second guide wire, the stent rotatably mountedrelative to the first guide wire so that insertion of the second guidewire into the side branch properly orients the stent.
 48. The assemblyof claim 47 farther comprising a balloon rotatably received on the firstguide wire.
 49. The assembly of claim 49 further comprising first andsecond rotating members received over the first guide wire and receivingcorresponding first and second ends of the balloon to permit selectiverotation of the balloon and passively orient the side branch guide wirevia the side branch passage.
 50. The assembly of claim 48 wherein thestent is self-expanding.
 51. The assembly of claim 47 further comprisinga balloon rotatably received on the fast guide wire for selectivelyexpanding the stent and a side branch guide wire Carrier.